Cortexa research tool·genomics·openfda

OpenFDA Search Device 510k

Search the FDA 510(k) premarket notification database via openFDA. Contains clearances for medical devices through the 510(k) pathway (substantial equivalence). Returns device names, applicant companies, decision dates, advisory committee classifications, and FDA decision types. Useful for medical device research, competitive landscape analysis, and understanding regulatory pathways for specific device categories.

Livelast probed 2026-04-30 23:07Z· 88msCortexa

Status

The most recent probe succeeded. Safe to call from the agent today.

Last probed: 1d ago
Last success: 1d ago
Last latency: 88ms

Schema

JSON Schema the agent (or your API call) must match.

{
  "properties": {
    "limit": {
      "description": "Maximum number of results (default 5, max 100)",
      "type": [
        "integer",
        "null"
      ]
    },
    "search": {
      "description": "Lucene query for 510(k) devices (e.g., 'device_name:stethoscope', 'applicant:siemens', 'decision_date_year:2023', 'advisory_committee_description:radiology')",
      "type": "string"
    }
  },
  "required": [
    "search"
  ],
  "type": "object"
}

Examples (1)

Default OpenFDA Search Device 510k call

public-safeinput

{
  "search": ""
}

Expected response keys: success

Anonymous-safe example. Rate-limited; no sign-in required.

Identifiers

Catalog ID: tu_OpenFDA_search_device_510k
Tool name: OpenFDA_search_device_510k
Added: 2026-04-30 22:47Z
Tags: tooluniverse

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